PGW

37 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ear, Nose, And Throat Stereotaxic Instrument

Device class

Class II (moderate risk)

Regulation

21 CFR 882.4560

Medical specialty

Neurology

FDA definition

Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Adverse events (MAUDE)

2021: 190 · 2022: 166 · 2023: 200 · 2024: 274 · 2025: 220 · 2026: 62
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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